tbuckley/cabot-search huggingface dataset:
Further insights on social determinants of health: Investigating racial disparities and estimated household income in relation to staging of newly diagnosed breast cancer.
Authors: Rina Ghorpade, Fiona Tissavirasingham, Deanne Loague, Andrea Escala Perez-Reyes, Varun Victor, Shivam Singla, Nitant Parekh, Yashaswi Ram Malipeddi, Shruti Trehan
Journal: Journal of Clinical Oncology (2023)

e22529 Background: The incidence of breast cancer in high-income countries has risen by over 20% in the past two decades, with higher incomes relating to higher incidence rates of breast cancer. Racial disparities relating to breast cancer have also been observed, with African American women being diagnosed with more aggressive and advanced-stage breast cancer. We aimed to study how racial disparities and household income relate to breast cancer staging at the time of diagnosis. Methods: A retrospective cohort study was conducted on 1000 breast cancer patients in Aultman hospital cancer center in Canton, Ohio. Patients with a diagnosis of breast cancer diagnosed between 2010-2020 were included in the study. Data including age, zip code, race, and tumor stage at the time of diagnosis was collected. Further, zip code information was used to estimate median household income by searching available US income statistics. For statistical analysis, the Pearson correlation and linear regression model were used, with p&lt; 0.05 defining statistical significance. Results: Patients ranged from 25-95 years old. The percentage of patients with breast cancer staging of 0, I, II, III, and IV was 1.9%, 47.7%, 26.2%, 6.1%, and 18.1% respectively. When separated by income bracket, 86.6% of the study population was found to be within the $44,251-$88,450 income bracket. Regarding income and breast cancer stage, a correlation coefficient of -0.019 (p 0.557) was found. Further, the population of study was found to be 51.4% Caucasian, 2% African American, 0% Hispanic, 0.3% Asian, and 46.3% other races. Regarding race and breast cancer stage, a correlation coefficient of -0.174 (p &lt; 0.01) was found. Conclusions: This study found no significant relationship between income and stage at the time of diagnosis. A limitation to our study was the use of estimated household income rather than exact patient reported income. However, a significant relationship was found between race and breast cancer staging, with earlier stage breast cancer detected among Caucasian women, and later stages among other races at the time of diagnosis. These findings emphasize the need to address racial disparities and access to care to improve upon breast cancer screening and early-stage detection.
Outcomes of Black (B) versus White (W) patients (pts) with metastatic hormone-sensitive prostate cancer (mHSPC) treated with androgen deprivation therapy (ADT) with or without orteronel (Ort): Analysis of pt-level data from SWOG-1216 phase 3 trial.
Authors: Nicolas Sayegh, Umang Swami, Yeonjung Jo, Georges Gebrael, Benjamin Haaland, Shilpa Gupta, Melissa Plets, Maha H. A. Hussain, David I. Quinn, Primo N Lara, Ian M Thompson, Neeraj Agarwal
Journal: Journal of Clinical Oncology (2023)

6532 Background: Despite more aggressive prostate cancer (PCa) at presentation and higher mortality in real world, B pts with metastatic hormone resistant PCa did not have inferior outcomes than W pts when both were enrolled in clinical trials (PMID: 33951180). In the phase 3 S1216 trial, treatment with Ort, a novel CYP17 axis inhibitor, significantly improved progression-free survival (PFS) but not overall survival (OS) compared to bicalutamide (Bic) in pts with mHSPC receiving ADT. This trial enrolled the greatest number of B pts in a phase 3 trial in this setting to-date. We hypothesized that given comparable access to care as experienced in a clinical trial, outcomes in B pts would be similar to those of W pts in the mHSPC setting. Methods: Eligibility: Pts with mHSPC were enrolled. Only pts self-identifying as B or W were included in this analysis. PFS and OS for each group were estimated using Kaplan-Meier method. A multivariate analysis (MVA) adjusting for disease characteristics was conducted using a Cox proportional hazards model. Results: Among 1279 participants, 135 (10.6%) were B; 1077 (84.2%) were W. B and W were equally distributed between treatment arms, and had respectively similar proportion of pts with Gleason score ≥8 (61.3 vs 62.1%), Zubrod score ≥2 (5.1 vs 3.4%) and extensive disease (48.1 vs 48.7%). However, B pts, as compared to W, were younger (65.8 vs 68.4 yrs, p=0.001) and had a higher median baseline PSA (54.7 vs 26.7 ng/mL; p&lt;0.001). PSA responses (≤ 0.2 ng/mL) at month 7 were similar in both groups (p=0.296). Overall, B vs W had similar median PFS (2.3 vs 2.9 yrs, p=0.71) and OS (5.5 vs 6.3 yrs, p=0.65). MVA confirmed similar PFS and OS after adjusting for known prognostic factors (Table). No interaction between race and treatment was observed (P-value interaction PFS= 0.77 and OS= 0.91). Conclusions: We demonstrate that even though B pts present with more aggressive disease in mHSPC setting, they did not have statistically significant worse OS and PFS than W pts and treatment effect was also similar for both racial groups. Equitable access to care may negate historical differences in outcomes among B vs W pts with advanced PCa. Funding: NIH/NCI/NCTN grant U10CA180888, U10CA180819; and Millennium Pharmaceuticals (Takeda Oncology). Univariate and MVA of PFS and OS. [Table: see text]
The phase 1 clinical trial of anti–PD-1 (pucotenlimab) plus intrahepatic injection of oncolytic virus (OH2) combined with radiotherapy of liver metastasis in stage IV melanoma.
Authors: Chuanliang Cui, Xuan Wang, Hongzhi Wang, Shanshan Yin, Yue Cong, Bin Lian, Caili Li, Jiayi Yu, Lu Si, Zhihong Chi, Xinan Sheng, Yan Kong, Lili Mao, Li Zhou, Bixia Tang, Xieqiao Yan, Xue Bai, Siming Li, Weihu Wang, Jun Guo
Journal: Journal of Clinical Oncology (2023)

e21545 Background: Melanoma pts with liver metastasis has poor prognosis and reduced response to systemic immunotherapy. Oncolytic herpes simplex virus 2 (OH2) is an oncolytic virus derived from herpes simplex virus type 2. PD-1 antibody combined with intrahepatic oncolytic virus intralesional injection had shown preliminary efficacy in previous clinical trial. The radiation of liver metastasis might exert action on its tumor microenvironment and get benefit from immunotherapy combination. So we perform this phase I study to assess the safety and efficacy of OH2 and pucotenlimab (a humanized immunoglobulin G4 monoclonal antibody) combine with liver metastasis radiation in melanoma pts. Methods: Eligible pts included those over 18 with injectable liver metastasis confirmed by biopsy with or without extra-hepatic metastasis; the ocular melanoma and brain metastasis were excluded. Pts received intravenous Pucotenlimab Q3W combined with ultrasound guided intrahepatic injection (metatstasis lesion) of OH2 Q2W (10 7 CCID50/mL, 8ml per injection) after stereotactic body radiotherapy (24-30Gy/3Fx) of liver metastasis. Liver biopsy performed at baseline and first tumor evaluation (8-12weeks). The primary endpoint was ORR; secondary:toxicity, DCR, PFS and OS. Results: From Dec 2021 to Jan 2023, 10 pts were eligible and enrolled. Baseline characteristics: 70% got previous treatment; LDH＞ULN 50.0%; 90% got extra-hepatic metastasis; median size of ed lesions: 36mm(19-120mm); median number of liver metastasis: 5.5. Among these pts, 5 pts could be evaluated for efficacy (follow-up 10.0 m). The global ORR by investigator was 40.0% (2/5), DCR 80% (4/5). Biopsies of 4 pts for injected lesions at 8 to 12 weeks after first injection were examined to determine the situation of tumor regression and TIL infiltration. Among them, 2 pts ( 1 PR and 1 SD) had no tumor cells residual by immunohistochemistry in biopsies with impressive TIL infiltration, both of them showed PFS more than12.0 months. Most adverse events (AE) were grade 1-2. Only one pts had grade 3-4 thrombocytopenia, with treatment modified. No treatment-related deaths occurred. The median PFS was not reached and now in follow up. Conclusions: Systemic anti-PD-1 plus intralesional injection of Oncolytic virus combined with radiotherapy has shown remarkable ORR and pathological response in melanoma pts with liver metastases with manageable toxicity. Clinical trial information: NCT05068453 . [Table: see text]
Impact of disadvantaged socioeconomic and demographic status on survival in Kaposi sarcoma.
Authors: Michelle Swedek, Xinxin Wu, Peter T. Silberstein, Victoria Vardell
Journal: Journal of Clinical Oncology (2023)

e21581 Background: Kaposi sarcoma (KS) is a soft tissue tumor that affects a wide variety of patient populations, though it is typically seen in immunocompromised patients, including those living with organ transplant or HIV/AIDS. Patients from traditionally underserved socioeconomic and demographic populations have historically had poor outcomes across malignancies, however these populations have never been studied on a large national scale in KS. To examine how socioeconomic and demographic status affects survival in KS, we examined the National Cancer Database (NCDB); a large oncology database that includes approximately 75% of newly diagnosed cancers across the United States. Methods: We conducted a retrospective analysis of the NCDB for KS patients diagnosed from 2004 to 2019. Cases missing data for variables of interest were excluded. Overall survival (OS) was examined using Kaplan-Meier and multivariate Cox regression. Results: A total of 5,233 patients with KS were identified, with a mean age of 58 years. Most patients were male (87.1%), White (70.1%), not Spanish/Hispanic (82.7%), and had government insurance (54.3%). Comorbid conditions were described using the Charlson-Deyo Comorbidity Score (CDS), and a substantial number of patients had a score above 3 (28.6%). The mean OS for all patients was 122 months. On adjusted Cox regression, decreased OS was seen in patients over 85 years old (HR 2.14, 95% CI 1.82-2.53, p&lt;0.001) compared to patients aged 40-54 years old. Compared to White patients, Black patients had decreased OS (HR 1.24, 95% CI 1.11-1.38, p&lt;0.001); mean survival in Black patients was 113 months compared to 124 months in White patients (p&lt;0.001). Improved OS was seen in patients of Spanish/Hispanic origin (HR 0.80, 95% CI 0.70-0.91, p&lt;0.001). Any CDS greater than 1 was associated with poor OS (HR 1.46 for CDS 1, 95% CI 1.26-1.70, p&lt;0.001), and treatment at an academic facility had a protective effect (HR 0.75, 95% CI 0.69-0.82, p&lt;0.001), as did private insurance (HR 0.65, 95% CI 0.55-0.77, p&lt;0.001). Biological sex, education, income, and facility location did not independently impact survival. Conclusions: When adjusted for key demographic covariates, advanced age, Black race, and presence of comorbidities were each independently associated with decreased OS in KS patients. Improved OS was seen with Spanish/Hispanic ethnicity, treatment at an academic facility, and private insurance. To our knowledge, our study is the first to describe demographic and socioeconomic features impacting survival for KS patients at this scale. We revealed important disparities in survival and highlight the need for equitable care in KS, especially for patients of Black race.
Validation of the Tagalog and Ilokano translations of the Functional Assessment of Cancer Therapy-General (FACT-G) scale for adult cancer center patients in a state-funded tertiary hospital.
Authors: Earnest Caiser Quilang Dela Cruz
Journal: Journal of Clinical Oncology (2023)

e18524 Background: Patient reported outcomes such as the health related quality of life (HRQOL) is a significant variable that should be used in clinical decision making and health policy. The Functional Assessment of Cancer Therapy - General (FACT-G), is one of the most widely used HRQOL questionnaires and to make it more accessible globally translation to local dialects are imperative for inclusive service delivery. Prior to use, the validity and reliability of these tools should be established for the population it is intended to cater. Consistent with the mission statement of the hospital the researcher wanted this service to be more accessible and equitable by addressing language differences for our non english speaking end-users. Hence, the study aimed to document validity and reliability of translated Tagalog and Ilokano versions of the FACT-G questionnaire for use in patients catered upon by the Baguio General Hospital and Medical Center (BGHMC). Methods: Psychometric evaluation of the above tools was done involving 384 adult cancer patients of BGHMC. Data management and analysis using SPSS software was used to evaluate reliability, face validity, content validity, and construct validity. An addition of cognitive interviews was done with end-users and subsequent thematic analysis aimed to improve questionnaire quality. Results: Both the Tagalog and Ilokano questionnaires had indices above the set value for reliability measured as Chronbach’s alpha of 0.968 and 0.974, content validity indices of 0.95 and 0.95, and face validity indices of 0.98 and 0.98, respectively. Construct validity was established through an exploratory factor analysis comprised of a principal components analysis and Varimax factor rotation with Kaiser normalization. Conclusions: The Tagalog and Ilokano questionnaires are reliable and valid tools for use of approximation of HRQOL of cancer patients catered by the BGHMC. With the results of the validation study it is recommended to incorporate the use of these translated questionnaires to the day to day health service provision to approximate the health-related quality of life of cancer patients. These can also be used as measures to evaluate interventions and policies that are directed towards cancer patients catered in Northern Luzon. To better these questionnaires the revised questionnaires includes the omission of the 7th item in the scale of general social and family well-being to minimize disruptions in rapport due to nature of the question. Another is the reversion of the 2nd item in the scale of general emotional well-being so that it would have the same direction on the approximation of HRQOL with the other items in the scale.
Predictors of survival outcomes in patients with <i>MECOM EVI1</i> rearrangement aberrations in AML or MDS.
Authors: Yael Kusne, Alyssa McGary, Katalin Kelemen, Mark Robert Litzow, Aref Al-Kali, James M. Foran, Talha Badar, Mrinal S Patnaik, Abhishek A Mangaonkar, Lisa Ostrosky Sproat, Jeanne M. Palmer, Patricia T. Greipp, Cecilia Ysabel Arana Yi
Journal: Journal of Clinical Oncology (2023)

e19078 Background: MECOM (EVI1) rearrangements in MDS/AML are rare and carry an unfavorable prognosis. Although allogeneic stem cell transplantation (allo-HSCT) may prolong survival, factors impacting outcomes are not known. We conducted a retrospective analysis of patients with MECOM (EVI1) to associate clinicopathologic variables with prognosis. Methods: This study was approved by the Mayo Clinic IRB. Patients &gt;18 years of age with MDS or AML and MECOM EVI1 at Mayo Clinic between 01/2012 and 12/2022 were included. Response was defined by ELN criteria. Intensive chemotherapy was defined as 7+3 or high dose cytarabine. Non-intensive chemotherapy included hypomethylating agents with or without venetoclax. Median overall survival (OS) and median leukemia free survival (LFS) were estimated using the Kaplan-Meier method. Outcome differences between sub-groups and univariate analyses were assessed with Cox regression. Results: Sixty patients met criteria for inclusion. Sixty-three percent (n = 38) were male and the median age at diagnosis was 67.8 yrs (range, 56 – 75). Eighty percent had AML (n = 48) and 18% had MDS (n = 11). Sixty-seven percent of patients had secondary AML/MDS (n = 40). Inv(3)/t(3;3) was present in 65% (n = 39) and t(3;21) was present in 12% (n = 7). Thirty-eight percent (n = 23) of patients had cooccurring monosomy 7 or 7q deletion and 5% had complex karyotype (n = 3). SF3B1 was the most common cooccurring mutation in 31% (n = 10), followed by KRAS in 19% (n = 6). Thirty-eight percent of patients (n = 23) received intensive chemotherapy. Complete response (CR) rates were 36% with intensive treatment (n = 8) and 4% with non-intensive treatment (n = 1; p = 0.007). Thirty percent (n = 18) underwent SCT (78% in CR1 and 22% in CR2) and of those, myeloablative conditioning (MAC) was used in 38% while 61% received reduced intensity conditioning (RIC). The mOS in the entire cohort was 11 months (95% CI 6.2, 17). Patients who received a SCT had longer mOS compared to patients who did not (19 vs 6.2 months, HR = 0.31, 95% CI 0.16,0.64; p = 0.001). AML-MRC was a poor prognostic factor in the HCST group for OS (HR = 4.23, 95% CI 1.02, 17.5, p = 0.047). Intensive vs. non-intensive chemotherapy, response prior to transplant (CR vs. no CR), or having 2 or more mutations on NGS did not significantly impact OS or LFS. Conclusions: In line with previous reports, allo-HSCT was associated with improved survival outcomes. Our results showed a high frequency of secondary AML/MDS, but only AML-MRC was associated with decreased survival outcomes. Regardless of therapy type, outcomes were poor. Novel therapies are urgently needed for these patients.
Survival in patients with unresectable melanoma: To infinity and beyond?
Authors: Olivier Jules van Not, Alfonsus Johannes Maria van den Eertwegh, John B. A. G. Haanen, Christian U. Blank, Maureen J.B. Aarts, Franchette van den Berkmortel, Jan Willem de Groot, Geke Hospers, Ellen Kapiteijn, Manja Bloem, Djura Piersma, Rozemarijn van Rijn, Marion Stevense - den Boer, Astrid Aplonia Maria Van Der Veldt, Gerard Vreugdenhil, Marye J. Boers-Sonderen, Willeke Blokx, Michel Wouters, Karijn Suijkerbuijk
Journal: Journal of Clinical Oncology (2023)

e21504 Background: The introduction of checkpoint inhibitors and targeted treatment has led to significant improvements in prognosis for melanoma patients over the last years. We aimed to evaluate the survival per year of diagnosis. Methods: All systemically treated patients diagnosed with advanced melanoma from 2013 to 2021 were included from the nationwide Dutch Melanoma Treatment Registry. Baseline characteristics, overall survival (OS), and melanoma-specific survival (MSS) were compared between the different years of diagnosis of unresectable melanoma. Results: In total, 6324 patients were included. Over the years, the age at start of treatment gradually increased. Patients treated in 2020 and 2021 more often had an Eastern Cooperative Oncology Group Performance Status (ECOG PS) ≥2 and synchronous metastatic disease (table). The percentage of patients receiving systemic treatment did not change over the years. Median OS gradually increased from 11.3 months (95%CI 10.1-12.5) for patients diagnosed in 2013 to 33.3 months (95%CI 28.8-37.4) for patients diagnosed in 2019. Remarkably however, median OS was lower for patients diagnosed in 2020 and 2021 (24.8 months; 95%CI 21.1-28.2 and 18.8 months; 95%CI 17.6-NR). When excluding previously adjuvant-treated patients or looking at synchronous metastatic melanoma only, the same trends were seen. Similarly, differences in MSS mirrored our OS findings. Median OS and MSS can be found in the table. Conclusions: After a continuous survival improvement for advanced melanoma patients between 2013-2019, outcomes in 2020 and 2021 are remarkably poorer. The decreased performance status at the start of systemic treatment suggests that COVID-related delays might have played a role. [Table: see text]
Outcomes of 3- versus 5-day administration schedule of consolidation cytarabine in adults with acute myeloid leukemia (AML).
Authors: Kendall Diebold, Kimo Bachiashvili, Omer Hassan Jamy, Pankit Vachhani, Kelly Nicole Godby, Ravi Bhatia, Barry Diamond, Josh D Oliver, Kaitlin R Moulton, Sravanti Rangaraju
Journal: Journal of Clinical Oncology (2023)

7014 Background: Consolidation therapy with intermediate to high-dose cytarabine is critical to prevent relapse in AML. Cytarabine is typically administered every 12 hours on days 1, 3, 5. Two large studies have examined a condensed 3-day administration schedule in patients &lt;60 years and demonstrated a shorter time to absolute neutrophil count (ANC) recovery without compromising long term outcomes. However, use of this regimen in patients ≥60 years has not been evaluated. Here we report our experience with the condensed administration schedule compared with the standard schedule in patients over and under 60 years. Methods: All patients with AML in first complete remission (CR) following intensive induction chemotherapy receiving consolidation at our institution between 1/1/2020 to 12/31/2021 were included in the study. Patients received cytarabine every 12 hours on days 1, 3, 5 (AC135) from 1/1/2020 – 12/31/2020 and cytarabine every 12 hours on days 1, 2, 3 (AC123) from 1/1/2021 – 12/31/2021. All patients received peg-filgrastim support. Data was collected to determine time to ANC recovery &gt;1,000/µL, hemoglobin (Hb) &gt;8g/dL, and platelets &gt;75,000/µL. Comparison of continuous variables between two groups was done using multiple t-tests. Results: Between 1/1/2020 - 12/31/2021, 91 patients received at least one cycle of consolidation with 212 individual encounters. 38 patients received all cycles with AC135, 45 received AC123, and 8 received at least one cycle each of AC123 and AC135. Median age of the AC123 cohort was 50.2 years (range 19-72 years) and 54.3 years for the AC135 cohort (range 22-72 years). For patients ≥60 years of age, 33% (71/213) of the encounters were in the AC123 cohort and the rest in AC135 cohort. Median dose of cytarabine was 5,100 mg/dose in AC123 and 4,600 mg /dose in AC135 (p=0.02). Median time to ANC recovery, hemoglobin, and platelets as well as hospital-related outcomes are described in the table. In patients ≥60 years, median time to ANC recovery was 16.5 vs. 18.6 days (p = 0.03) and platelet recovery was 17.4 vs. 19.7 (p = 0.0008) in AC123 vs AC135 respectively. No neurotoxicity events were noted. Complication rates were similar in both arms. Conclusions: Our study demonstrates that AC123, as compared to AC135, is safe and leads to earlier hematopoietic recovery in adults under and over 60 years. AC123 should be considered the preferred schedule of consolidation therapy administration. [Table: see text]